Terbutaline Sulfate


General Injectables & Vaccines, Inc
Human Prescription Drug
NDC 52584-665
Terbutaline Sulfate is a human prescription drug labeled by 'General Injectables & Vaccines, Inc'. National Drug Code (NDC) number for Terbutaline Sulfate is 52584-665. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Terbutaline Sulfate drug includes Terbutaline Sulfate - 1 mg/mL . The currest status of Terbutaline Sulfate drug is Active.

Drug Information:

Drug NDC: 52584-665
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Terbutaline Sulfate
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Terbutaline Sulfate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: General Injectables & Vaccines, Inc
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Injection, Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:TERBUTALINE SULFATE - 1 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:SUBCUTANEOUS
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
Marketing Start Date: 16 Nov, 2011
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 31 Mar, 2024
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA076887
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
Listing Expiration Date: 14 Jun, 2026
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:General Injectables & Vaccines, Inc
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:857635
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
UNII:576PU70Y8E
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
52584-665-011 VIAL in 1 BAG (52584-665-01) / 1 mL in 1 VIAL16 Nov, 201131 Mar, 2024No
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Terbutaline sulfate terbutaline sulfate terbutaline sulfate terbutaline

Indications and Usage:

Indications & usage terbutaline sulfate injection, usp is indicated for the prevention and reversal of bronchospasm in patients 12 years of age and older with asthma and reversible bronchospasm associated with bronchitis and emphysema.

Warnings:

Warnings deterioration of asthma asthma may deteriorate acutely over a period of hours or chronically over several days or longer. if the patient needs more doses of terbutaline than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. use of anti-inflammatory agents the use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids. cardiovascular effects terbutaline, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. although such effects are uncommon after administration of terbutaline at recommended doses, if they occur, the drug may need to be disco
ntinued. in addition, beta-agonists have been reported to produce electrocardiogram (ecg) changes, such as flattening of the t wave, prolongation of the qtc interval, and st segment depression. the clinical significance of these findings is unknown. therefore, terbutaline, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. seizures there have been rare reports of seizures in patients receiving terbutaline; seizures did not recur in these patients after the drug was discontinued.

Dosage and Administration:

Dosage & administration terbutaline sulfate injection, usp should be used only for subcutaneous administration and not intravenous infusion. sterility and accurate dosing cannot be assured if the vials are not used in accordance with dosage and administration. discard unused portion after single patient use. the usual subcutaneous dose of terbutaline sulfate injection, usp is 0.25 mg injected into the lateral deltoid area. if significant clinical improvement does not occur within 15 to 30 minutes, a second dose of 0.25 mg may be administered. if the patient then fails to respond within another 15 to 30 minutes, other therapeutic measures should be considered. the total dose within 4 hours should not exceed 0.5 mg. note: parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Contraindications:

Contraindications prolonged tocolysis terbutaline sulfate has not been approved and should not be used for prolonged tocolysis (beyond 48 to 72 hours). in particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting (see boxed warning: prolonged tocolysis). hypersensitivity terbutaline sulfate injection is contraindicated in patients known to be hypersensitive to sympathomimetic amines or any component of this drug product.

Adverse Reactions:

Adverse reactions adverse reactions observed with terbutaline are similar to those commonly seen with other sympathomimetic agents. all these reactions are transient in nature and usually do not require treatment. the following table compares adverse reactions seen in patients treated with terbutaline (0.25 mg and 0.5 mg), with those seen in patients treated with epinephrine injection (0.25 mg and 0.5 mg), during eight double-blind crossover studies involving a total of 214 patients. incidence (%) of adverse reactions terbutaline (%) terbutaline (%) 0.25 mg n=77 0.5 mg n=205 reaction central nervous system tremor 7.8 38 nervousness 16.9 30.7 dizziness 1.3 10.2 headache 7.8 8.8 drowsiness 11.7 9.8 cardiovascular palpitations 7.8 22.9 tachycardia 1.3 1.5 respiratory dyspnea 0 2 chest discomfort 1.3 1.5 gastrointestinal nausea/vomiting 1.3 3.9 systemic weakness 1.3 0.5 flushed feeling 0 2.4 sweating 0 2.5 pain at injection site 2.6 0.5 epinephrine (%) epinephrine (%) 0.25 mg n=153 0.5 mg
n=61 reaction central nervous system tremor 16.3 18 nervousness 8.5 31.1 dizziness 7.8 3.3 headache 3.3 9.8 drowsiness 14.4 8.2 cardiovascular palpitations 7.8 29.5 tachycardia 2.6 0 respiratory dyspnea 2 0 chest discomfort 2.6 0 gastrointestinal nausea/vomiting 1.3 11.5 systemic weakness 2.6 1.6 flushed feeling 1.3 0 sweating 0 0 pain at injection site 2.6 1.6 note: some patients received more than one dosage strength of terbutaline and epinephrine. in addition, there were reports of anxiety, muscle cramps, and dry mouth (less than 0.5%). there have been rare reports of elevations in liver enzymes and of hypersensitivity vasculitis with terbutaline administration.

Adverse Reactions Table:

Incidence (%) of Adverse Reactions
Terbutaline (%)Terbutaline (%)
0.25 mg N=770.5 mg N=205
Reaction
Central Nervous System
Tremor7.838
Nervousness16.930.7
Dizziness1.310.2
Headache7.88.8
Drowsiness11.79.8
Cardiovascular
Palpitations7.822.9
Tachycardia1.31.5
Respiratory
Dyspnea02
Chest discomfort1.31.5
Gastrointestinal
Nausea/vomiting1.33.9
Systemic
Weakness1.30.5
Flushed feeling02.4
Sweating02.5
Pain at injection site2.60.5
Epinephrine (%)Epinephrine (%)
0.25 mg N=1530.5 mg N=61
Reaction
Central Nervous System
Tremor16.318
Nervousness8.531.1
Dizziness7.83.3
Headache3.39.8
Drowsiness14.48.2
Cardiovascular
Palpitations7.829.5
Tachycardia2.60
Respiratory
Dyspnea20
Chest discomfort2.60
Gastrointestinal
Nausea/vomiting1.311.5
Systemic
Weakness2.61.6
Flushed feeling1.30
Sweating00
Pain at injection site2.61.6

Overdosage:

Overdosage the median sc lethal dose of terbutaline in mature rats was approximately 165 mg/kg (approximately 2,700 times the maximum recommended daily sc dose for adults on a mg/m2 basis). the median sc lethal dose of terbutaline in young rats was approximately 2,000 mg/kg (approximately 32,000 times the maximum recommended daily sc dose for adults on a mg/m2 basis). the expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of any of the symptoms listed under adverse reactions, e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and insomnia. hypokalemia may also occur. there is no specific antidote. treatment consists of discontinuation of terbutaline together with appropriate symptomatic therapy. the judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. there is insufficient evidence to determine if dialysis is beneficial for overdosage of terbutaline.

Description:

Description rx only a sterile aqueous solution for subcutaneous injection. warning: prolonged tocolysis terbutaline sulfate has not been approved and should not be used for prolonged tocolysis (beyond 48 to 72 hours). in particular, terbutaline sulfate should not be used for maintenance tocolysis in the outpatient or home setting. serious adverse reactions, including death, have been reported after administration of terbutaline sulfate to pregnant women. in the mother, these adverse reactions include increased heart rate, transient hyperglycemia, hypokalemia, cardiac arrhythmias, pulmonary edema and myocardial ischemia. increased fetal heart rate and neonatal hypoglycemia may occur as a result of maternal administration (see contraindications, prolonged tocolysis). description terbutaline sulfate injection, usp, is a beta-adrenergic agonist bronchodilator available as a sterile, nonpyrogenic, aqueous solution in vials, for subcutaneous administration. each ml of solution contains: 1 mg of terbutaline sulfate usp (0.82 mg of the free base), and water for injection, usp. sodium chloride is used for isotonicity, and hydrochloric acid for adjustment to a ph of 3.0 to 5.0. terbutaline sulfate is (±)-a-[(tert-butyl-amino) methyl]-3,5-dihydroxybenzyl alcohol sulfate (2:1) (salt). the structural formula is: terbutaline sulfate usp is a white to gray-white crystalline powder. it is odorless or has a faint odor of acetic acid. it is soluble in water and in 0.1n hydrochloric acid, slightly soluble in methanol, and insoluble in chloroform. formula1.jpg

Clinical Pharmacology:

Clinical pharmacology terbutaline is a beta-adrenergic receptor agonist. in vitro and in vivo pharmacologic studies have demonstrated that terbutaline exerts a preferential effect on beta2-adrenergic receptors. while it is recognized that beta2-adrenergic receptors are the predominant receptors in bronchial smooth muscle, data indicate that there is a population of beta2-receptors in the human heart, existing in a concentration between 10% to 50%. the precise function of these receptors has not been established (see warnings). controlled clinical studies in patients given terbutaline subcutaneously have not revealed a preferential beta2-adrenergic effect. the pharmacologic effects of beta-adrenergic agonists, including terbutaline, are at least in part attributable to stimulation through beta-adrenergic receptors of intracellular adenyl cyclase, the enzyme which catalyzes the conversion of adenosine triphosphate (atp) to cyclic 3’,5’-adenosine monophosphate (camp). increased
camp levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells. controlled clinical studies have shown that terbutaline relieves bronchospasm in acute and chronic obstructive pulmonary disease by significantly increasing pulmonary flow rates (e.g., an increase of 15% or more in fev1). after subcutaneous administration of 0.25 mg of terbutaline, a measurable change in expiratory flow rate usually occurs within 5 minutes, and a clinically significant increase in fev1 occurs within 15 minutes. the maximum effect usually occurs within 30 to 60 minutes, and clinically significant bronchodilator activity may continue for 1.5 to 4 hours. the duration of clinically significant improvement is comparable to that observed with equimilligram doses of epinephrine. preclinical studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrhythmias and sudden death (with histological evidence of myocardial necrosis) when beta-agonists and methylxanthines are administered concurrently. the clinical significance of these findings is unknown. pharmacokinetics subcutaneous administration of 0.5 mg of terbutaline to 17 healthy, adult, male subjects resulted in mean (sd) peak plasma terbutaline concentration of 9.6 (3.6) ng/ml, which was observed at a median (range) time of 0.5 (0.08 to 1) hours after dosing. the mean (sd) auc (0 to 48) and total body clearance values were 29.4 (14.2) hr • ng/ml, and 311 (112) ml/min respectively. the terminal halflife was determined in 9 of the 17 subjects and had a mean (sd) of 5.7 (2) hours. after subcutaneous administration of 0.25 mg of terbutaline to two male subjects, peak terbutaline serum concentrations of 5.2 and 5.3 ng/ml were observed at about 20 minutes after dosing. elimination half-life of the drug in 10 of 14 patients was approximately 2.9 hours after subcutaneous administration, but longer elimination half-lives (between 6 to 14 hours) were found in the other 4 patients. about 90% of the drug was excreted in the urine at 96 hours after subcutaneous administration, with about 60% of this being unchanged drug. it appears that the sulfate conjugate is a major metabolite of terbutaline and urinary excretion is the primary route of elimination.

How Supplied:

How supplied discard unused portion after single patient use. store at 20° to 25°c (68° to 77°f) [see usp controlled room temperature]. protect from light. do not use if solution is discolored. vial stoppers do not contain natural rubber latex. app app pharmaceuticals, llc schaumburg, il 60173 451001d revised: february 2011 image1.jpg

Package Label Principal Display Panel:

Package label.principal label1.jpg


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